A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Guangzhou University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01812421
First received: March 14, 2013
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are asked to participate in our pre specified hypertension health education protocol (HHEP) after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and cardiovascular diseases.

HHEP consists of several items such as controlling the patient's hypertension level, monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension like tobacco smoking, obesity, and motivating the patient to physical activity and to a healthy diet.

Patients will receive visits by a study nurse with the aim of supervising, monitoring, and recording the adherence of HHEP. The patients will be classified as different adherence level at the end of the study according to their adherence condition.

This study is aimed at testing the hypothesis that controlling hypertension and its risk factors was more effective than those do not receive HHEP in reducing the recurrence of stroke and cardiovascular diseases.


Condition Intervention
To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.
Other: Hypertension Health Education Protocol (HHEP)

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Nonfatal vascular events: ischemic or hemorrhagic stroke recurrence (ICD-9 431 or ICD-10 I61), or myocardial infarction(MI) (ICD-9 410 or ICD-10 I21). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular death (death within 30 days after a vascular event) and all-cause mortality. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ischemic Stroke or TIA (ISTIA) patients Other: Hypertension Health Education Protocol (HHEP)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants were eligible for this observational cohort study if they were age 18 years or older; Hospitalized for a primary diagnosis of acute ischemic stroke or Transient Ischemic Attack (TIA) and concurrently diagnosed as hypertension; Provided consent to participate, and their data can be collected from Medical Record System of our hospital.

Exclusion Criteria:

We will exclude people who are onset of symptoms 3 months after their ischemic stroke or TIA; The stroke events occurred before the baseline survey were identified from the Hospital Discharge Register retrospectively and excluded from the analyses.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812421

Contacts
Contact: YeFeng Cai, Dr. zizi_33@126.com

Locations
China, Guangdong
Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: YeFeng Cai, Dr.       zizi_33@126.com   
Sub-Investigator: ZiYi Zhou, Master         
Sub-Investigator: Lin Wei, Master         
Sub-Investigator: XiaoPei Zhang, Master         
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01812421     History of Changes
Other Study ID Numbers: B2013-036-01
Study First Received: March 14, 2013
Last Updated: April 1, 2013
Health Authority: Science and Technology Department of Guangdong Province: China

Additional relevant MeSH terms:
Recurrence
Stroke
Cerebral Infarction
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 28, 2014